MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CADIERE FORCEPS

Model Number	430300-02
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted radical extraperitoneal prostatectomy without lymphadenectomy surgical procedure, non-intuitive motions occurred on an instrument (k10250918-0025) that was installed on universal surgical manipulator (usm) 2.A technical support engineer (tse) was contacted by the customer for troubleshooting.The tse checked the system logs and found several engagement errors recorded on usm 2.The tse asked the customer to reseat the sterile adapter and instrument on usm 2.The caller stated that the issue persisted.The tse then asked the customer to install a different instrument on usm 2.The caller reported that with a different instrument the issue was resolved.The tse asked the caller to re-install the affected instrument on usm 2.The caller stated that the issue reappeared, confirming that the problem was related to the cadiere forceps instrument.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the surgeon's head was inside the viewer and the issue occurred while the surgeon was trying to manipulate instruments.The instrument did not move in the intended direction, left observed direction equaled right.There were no collisions observed.The issue was resolved by using a backup instrument.

• Brand Name: ENDOWRIST SP
• Common Device Name: CADIERE FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 24328478
• Report Number: 2955842-2026-04100
• Device Sequence Number: 10030495
• Product Code: NAY
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430300-02
• Device Catalogue Number: 430300
• Device Lot Number: K10250918 0025
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male